Tuesday, February 14, 2012

BPAI says incorporation by reference requires "specific journal, volume, and page number for the citation"

Takeaway: A biotechnology patent application dealing with soluble protein mutants for treating melanoma referred to a non-patent article as "Ujvari et al., 2001." During prosecution, the Applicant amended the specification to include information from this article in order to overcome written description and indefiniteness rejections. The Examiner then objected to the amendment as new matter, finding that the specification's incorporation by reference was ineffective because the article was referred to only by author name and year. On appeal, the Board agreed, finding that the "original Specification failed to provide written descriptive support for a citation to a particular Ujvari reference by a specific journal, volume, and page number for the citation." The Board noted that the general statement “[a]ll of the publications and patent applications and patents cited in this specification are herein incorporated in their entirety by reference” was not sufficient. (Ex parte Petrescu, BPAI 2011.)

Ex parte Petrescu
Appeal 2010002359; Appl. No.10/959,600; Tech. Center 1600
Decided May 20, 2011

The biotechnology application on appeal related to soluble protein mutants and methods for treating melanoma with these proteins.

During prosecution, the Examiner issued a written description rejection for an amended claim, explaining that the specification was deficient in several ways. First, "the specification is unclear about the size of the transmembrane domain of the tyrosinase that is truncated." Next, the specification referred to position 81 rather than claimed position 86. Finally, the specification referred to "position 81" but lacked a reference to a sequence id number.

The Applicant filed an After Final response and addressed the rejection by asserting that both size and sequence number information were provided in a journal article, one that was incorporated by reference into the application.
With regard to the size of the transmembrane domain, applicants respectfully assert that human tyrosinase is a type I membrane glycoprotein that has 553 amino acids with one C-terminal transmembrane domain. This information is published in Ujvari et al., J. Biol. Chem., 276:5924-593 1 (2001), which is incorporated by reference in the present application. ... Furthermore, Ujvar ... provides GenBank accession number Y00819 as the sequence for the human tyrosinase gene.

When an Advisory Action indicated that the rejection was not overcome, the Applicant then filed an RCE. The Applicant maintained that the journal article provided written description support for new claims referring to position 86 in sequence number id 6 as well as for the previous amendments. The Applicant also amended the specification so that "the primers listed in Example 2 [now] refer to SEQ ID NOs," including claimed id 6.

In the next non-final Office Action, the Examiner maintained the written description rejection and also entered a new matter objection. According to the Examiner, the incorporation by reference was ineffective:
The complete reference of Ujvari et al., 3. Biol. Chem., 276:5924-5931 (2001) [discussed in the response] is not part of the original specification. The instant specification on page 6, paragraph 0026, recite the reference as Ujvari et al, 2001. There is no details of the reference in the instant specification as originally filed about the Journal. Vol. No. or Pages. Therefore, incorporating Ujvari et al., J. Biol. Chem., 2765924-5931 (2001), by reference introduces new matter. Further, the sequence of SEQ ID NO: 6 and 7 was never a part of the sequence listing, and incorporating these sequences via the incomplete reference of Ujvari et al. would be improper as well.

The Applicant filed a response arguing that the incorporation by reference was proper:
[T]he only Ujvari publication published in 2001 that relates to tyrosinase is Ujvari et al., JBiol Chem, 276(8):5924-3 (2001), and therefore, it is obvious that applicants' recitation of Ujvari 2001 in the specification refers to this JBC article.

When the final Rejection maintained the written description rejection and new matter objection, the Applicant appealed. The Appeal Brief argued that the incorporation by reference was proper because the specification included a citation to "Ujvari et al. 2001" coupled with the statement "All of the publications and patent applications and patents cited in this specification are herein incorporated in their entirety by reference." The Applicant then explained in detail why "Ujvari et al. 2001" amounted to a "full citation":
[E]ven a broad Google search reveals only one Ujvari et al, 2001 reference, and that is : Ujvari, Aron R, Eisenhaure T, Cheng E, Parag HA, Smicun Y, Halaban R, Hebert DN 2001 Translation rate of human tyrosinase determines its N-linked glycosylation level. J Biol Chem. 276(8):5924-3 1. In addition, search of the NCBI's PubMed database reveals that only one reference listing Ujvari as first author was published in 2001, and the reference relates to tyrosinase and is found in the Journal of Biological Chemistry (J Biol Chem, 276(8):5924-3 (2001)). Furthermore, the Ujvari reference describes that tyrosinase has 7 N-glycosylation sites, two copper binding domains and one C-terminal TM domain, as stated in the specification just before the Ujvari reference is cited. Accordingly, it is clear that the Ujvari  2001 reference cited and incorporated in the specification is Ujvari et al al., J Biol Chem, 276(8):5924-3 (2001). Therefore, the Ujvari reference was properly incorporated into the specification. Material is "in" the specification if it is incorporated by reference.
(Emphasis added.)

The Applicant's written description argument essentially relied on the specification as amended.

The Examiner's Answer commented on the arguments from the Appeal Brief as follows:
   The blanket incorporation by reference statement in the specification does not sufficiently point to which material was intented to be incorporated from which document. The complete and clear identity of the referenced patent, application, or publication is not uniquely identified as required bv 37 CFR 1.57(a) such that correction can be made.
   Moreover, 37 CFR 1.57 does not permit incorporation from references which need to be identified bv further searching for a partially described reference such as Ujvari et al. (2001 ) [without the Journal name, volume or page number] with a broad or narrow "Google Search" or "search of the NCBl's PubMed database" in order to determine which of the existing literature references by the same author to be most relevant, applicable and suitable for "incorporation by reference". 37 CFR 1.57 applies even if the authors publishing field is quite narrow.

As a threshold matter, the Board found that the Examiner's new matter objection rose to the level of an appealable rather than a petitionable matter, citing MPEP § 2163.06 (When “both the claims and specification contain new matter  either directly or indirectly, and there has been both a rejection and objection by the examiner, the issue becomes appealable.”).

The Board found that while the specification did properly incorporate a U.S. patent by reference, "there is no specific incorporation of Ujvari by reference." The Board then dismissed Applicant's argument that “only one reference listing Újvári as first author was published in 2001” as an "unsupported contention of Appellant's counsel." Finally, the Board noted that while another published paper did refer to the full citation, this "falls short of suggesting that this specific reference is the only 2001 reference, available to the public, that lists Ujvari as first author."

The Board then affirmed:
Absent evidence to the contrary, we are constrained to find that the preponderance of evidence on this record supports a conclusion that the original Specification failed to provide written descriptive support for a citation to a particular Ujvari reference by a specific journal, volume, and page number for the citation.

My two cents: If there was ever any doubt, this decision emphasizes the need to fully specify a citation rather than to use a shorthand abbreviation. The Applicant made some creative arguments (Google search, PubMed), but it makes sense to me that the Board insisted on "specific journal, volume, and page number."

I don't see incorporation by reference a lot in the applications I prosecute. Perhaps it's more common in other technology areas such as biotech.


  1. What was lacking was the argument that one of ordinary skill in the art would have been able to identify the article based on the information provided.

  2. >argument that a POSITA would have been
    >able to identify the article based on the
    >information provided.

    So the requirement in 1.57 to "Clearly identify the referenced patent, application, or publication" is from the viewpoint of a POSITA?

    I dunno if this is how the rule is interpreted or not. I agree that what's not clear to a layman can be nonetheless clear to a POSITA.

    But to me, the issue here goes more to "how clear" rather than "clear to who".

    The Applicant argued that the "clearly identified" standard was met because a Google search found only one reference published in 2001 that listed Ujvari as first author.

    The Board chose to ignore this argument as "an unsupported contention", ie, "mere attorney argument."

    A more interesting case would be if the Applicant had submitted evidence to support the argument.

    That should force the Board to specifically address the "clearly identify" standard.

  3. Lazy attorney gets his azz handed to him. No -- I'm not 6, but I've channeled him for a moment.

    Not much of an excuse for this. If you cite an article/patent/publication in your specification: (1) make sure you identify it (i.e., "that article by Bob" isn't enough) and (ii) include the phrase "which is incorporated herein by reference in its entirety." Pretty simple.

  4. "A more interesting case would be if the Applicant had submitted evidence to support the argument."


    "Not much of an excuse for this. If you cite an article/patent/publication in your specification: (1) make sure you identify it"


  5. Even if Applicant had included a specific citation to the Ujvari paper, I don't think it would have helped.

    Rule 1.57(c)-"Essential material" may be incorporated by reference, but only by way of an incorporation by reference to a U.S. patent or U.S. patent application publication. . .

    Applicant wanted to incorporate by reference essential material from a non-patent publication. Rule 1.57 does not allow that.

  6. >Not much of an excuse for this.

    Agreed. To me, the most interesting aspect here is what arguments you might use later in prosecution, to recover from the mistake.

    >incorporate by reference essential material
    >from a non-patent publication.

    Interest that neither the Board nor the Examiner brought this up. Would have been dispositive, right?

    Also interesting: in the Appeal Brief the Applicant refers to the stuff at issue as "essential material."

    [T]he originally filed specification provides the description of essential material concerning the wild-type human tyrosinase, citing the Ujvari reference (Ujvari et al., 2001) ...

    Did the Applicant shoot himself in the foot with this statement?

  7. The Applicant shot himself all over. If the practitioner who filed the appeal is the same one who drafted the application, they messed up big time. While I believe that a PHOSITA would have been able to identify the cited article with the information provided, the person who drafted the application should have provided as much citation information as possible. If this was essential descriptive subject matter, they should have made sure it was incorporated into the actual description instead of merely by reference.

  8. Pretty shoddy work from a well known, and expensive, firm.

  9. "Pretty shoddy work from a well known, and expensive, firm."

    Not knowing the history of who drafted the application versus who prosecuted the application, I'm hestitant to impute the shoddiness to the firm. Unless, of course, the firm is gaining a reputation for a culture that allows shoddy work.

    I've prosecuted enough applications drafted by other practitioners to know how difficult it can be to turn a sow's ear into a silk purse.

  10. The firm in question was listed on the transmittals for both the provisional and non-provisional. Not proof that they wrote it, but if they did, it speaks poorly of them.